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在接受治疗的局部晚期或转移性泌尿腺癌患者中,阿特佐利祖马布与化疗相比 (IMvigor211):多中心,开放性,第三阶段随机对照试验

Thomas Powles1, Ignacio Durán2, Michiel S van der Heijden3

  • 1Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK.

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概括
此摘要是机器生成的。

与化疗相比,阿特佐利祖马布对晚期泌尿器癌患者的整体存活率没有显著改善. 然而,阿特索利祖马布显示出更有利的安全性和持久反应,为这一患者群体提供了有价值的选择.

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科学领域:

  • 癌症学
  • 免疫疗法
  • 尿癌的治疗方法

背景情况:

  • 对于在化疗后进展的局部晚期或转移性尿路细胞癌患者,存在有限的治疗选择.
  • 作为这种患者群体的潜在治疗方法,研究了一种抗编程死亡配体1 (PD- L1) 疗法,Atezolizumab.

研究的目的:

  • 评估与标准化疗相比,阿特佐利祖马布的安全性和有效性,在经过以白金为基础的化疗后进展的转移性尿路细胞癌患者中.
  • 评估两个治疗组的整体存活率,客观反应率和不良事件.

主要方法:

  • 一个多中心的,开放的,随机对照的第三阶段试验 (IMvigor211) 涉及931名患者.
  • 患者被随机分配每3周接受阿特佐利祖马布 (1200毫克) 或医生选择的化疗 (文弗鲁宁,帕克利塔克塞尔或多塞塔克塞尔).
  • 随机化根据PD- L1表达水平,化疗类型,肝转移和预后因素进行分层.

主要成果:

  • 在PD- L1表达IC2/ 3群体中,阿特佐利祖马布和化疗组的总生存期没有显著差异 (中位数为11. 1个月与10. 6个月;HR为0. 87).
  • 在IC2/3群体中,确定的客观反应率相似 (23%对22%).
  • 与化疗相比,阿特佐利祖马布的安全性较好,与治疗相关的3 - 4级不良事件较少 (20%对43%),治疗中止较少 (7%对18%).

结论:

  • 在患有过度表达PD- L1 (IC2/ 3) 的白金耐药转移性尿道癌的患者中,阿特佐利祖马布的整体存活时间没有明显超过化疗.
  • 阿特佐利祖马布的安全性比化疗更好.
  • 在预期治疗群体中,探索性分析表明阿特佐利祖马布的耐受性和持续性反应.